Allos Therapeutics, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc

Important Safety Information

Warnings and Precautions

• FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit and/or reduce dose for hematologic toxicities.
• Mucositis may occur. Monitor at least weekly. If ≥Grade 2 mucositis is observed, omit and/or reduce dose. Patients should be instructed to take folic acid and receive vitamin B₁₂ to potentially reduce treatment-related hematological toxicity and mucositis.
• Dermatologic reactions, including fatal reactions, have occurred and may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and omit, and/or reduce dose or discontinue FOLOTYN.
• Tumor lysis syndrome may occur. Monitor patients and treat promptly.
• FOLOTYN can cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and if abnormalities are ≥Grade 3, omit until recovery then reduce dose or discontinue FOLOTYN as required.
• Patients with moderate to severe renal function impairment may be at greater risk for increased exposure and toxicity. Monitor patients for renal function and systemic toxicity and adjust dosing accordingly. Avoid FOLOTYN use in patients with end stage renal disease including those undergoing dialysis unless the potential benefit justifies the potential risk.
• FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.

Adverse Reactions

• The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Drug Interactions

• Co-administration with probenecid or other drugs that may affect relevant transporter systems (eg, NSAIDs), requires close monitoring for signs of systemic toxicity.

Use in Specific Populations

• Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
• Approximately one third of the administered dose of FOLOTYN is cleared by the kidneys. FOLOTYN has not been studied in patients with renal impairment.